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Qualified Person (QP) with Biologics Experience - Oferta z Jobs.pl

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Qualified Person (QP) with Biologics Experience

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  • A Qualified Person (QP) with Biologics or Steriles experience for an international pharmaceutical manufacturing site in Dublin.The company is looking for a Qualified Person with experience working with Biologics or Sterile Products. This role entails batch release as well as auditing and helping with clients general GMP related issues.This role will include no line-management responsibility, but will include project management/leadership where applicable. The client is interested in applicants with an established background in the Pharmaceutical or Contract Manufacturing Industry, specifically having experience with the manufacturing and distribution of Biological or Sterile products.TasksOversee batch release.Help with the maintenance of the QMS, and assist in answering any questions to do with GMP related issues.Other responsibilities in line with your experience may be requested on an ad-hoc basis.Provide quality expertise and oversight of cGMP activities across the site.Manage QA team through QA Managers to provide quality and compliance support for the site.Ensure Qualified Person support for site and global batch release.Help with training of other employees where necessary.Ensure preparation and support for regulatory and external inspections.Work collaboratively with support departments while ensuring high cGMP standards.Be an effective and engaged member of the broader Quality Leadership and Extended Leadership teams.Strong leadership and personnel development skills.RequirementsMust hold EU Qualified Person status.Experience working with Biologic/Sterlie products.Experienced in GMP3-5 years' experience in management of QA.Project Management and Quality Systems Management Experience.Extensive experience hosting of Regulatory (FDA/HPRA/Worldwide) and Corporate Inspections.This will only be considered as a full-time permanent position; the client will be open to assisting with relocation as part of the full package where suitable. If you are interested to hear more about this opportunity or to see how we may be able to help you further we are looking forward to receiving your application.


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